CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 2,400 target
Drug / intervention
Carboplatin +9 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • Histologically confirmed triple-negative breast cancer: ER <5%, PR <5%, HER2 negative per 2020 ASCO/CAP guidelines
  • AJCC 8 anatomic stage either T2-T4 N0 M0 or T1-T3 N1-2 M0
  • Breast and axillary imaging with mammogram and/or ultrasound and/or MRI within 49 days prior to randomization
  • Bilateral invasive breast cancer eligible if both ER-negative, PR-negative, HER2-negative and meet other criteria
Key exclusion· 19
  • T4/N+, any N3, or inflammatory breast cancer
  • Metastatic disease (M1)
  • Current or anticipated use of other investigational agents while participating in study
  • History of allergic reactions to compounds of similar chemical or biologic composition as study agents

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05929768
NCT05929768Phase 3RecruitingHigh MomentumUpdated 7mo ago

Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study

SWOG Cancer Research Network·interventional·Posted Jul 3, 2023·Updated Nov 5, 2025

In Brief

A Phase 3 clinical trial evaluating Biospecimen Collection, Carboplatin, and 8 other interventions for Anatomic Stage I Breast Cancer AJCC v8 and 4 related conditions. Currently recruiting, targeting 2,400 participants across 963 sites in 3 countries.

Signals

Enrolling ahead of pace

Detailed Summary

This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.

Study Details

Timeline

Phase 3Recruiting
2024202520262027202820292030203120322033
First PostedJul 3, 2023
Enrollment StartSep 15, 2023
Primary CompletionMar 31, 2033
Study CompletionApr 1, 2033
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 3.0 years agoPrimary completion in 6.7 years

Interventions

Biospecimen Collectionprocedure

Undergo collection of blood samples

Carboplatindrug

Given IV

Cyclophosphamidedrug

Given IV

Docetaxeldrug

Given IV

Doxorubicindrug

Given IV

Paclitaxeldrug

Given IV

Pembrolizumabbiological

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Surgical Procedureprocedure

Undergo surgery